Module 9 2021

23/03/2021

What could be the New Normal?

Development

New Normal?

Greater consultation between regulator and industry

Efficiency Gain

Clinical development flexibilities to allow parallel development

Old Normal

Pandemic

Registration Procedures

Labelling Single language labels + use of QR codes/e-labels

Pandemic response guidance/laws/regulations

Expedited procedures for product approvals

Remove expiry date – link though QR code

Reliance Mechanisms (use of reference agency)

Post-Approval Changes

Accelerated, reliance-type approaches

Supply/Manufacturing Remote GMP inspections reliance on country of manufacture

Use of a risk-based analytical comparability assessment (and use of protocols)

Multi-sourcing and risk-based validations approaches

Reliance + mutual recognition for local batch release

63

Current and Future Opportunities

64

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